131st MAINE LEGISLATURE

Printed on recycled paper

FIRST SPECIAL SESSION-2023

Legislative Document

No. 1914

S.P. 774

In Senate, May 9, 2023

An Act to Enact the Maine Psilocybin Health Access Act

Reference to the Committee on Health and Human Services suggested and ordered printed.

DAREK M. GRANT

Secretary of the Senate

Presented by Senator BAILEY of York.

Cosponsored by Representative THERIAULT of Fort Kent and

Senators: BRAKEY of Androscoggin, BRENNER of Cumberland, Representatives:

ANKELES of Brunswick, BOYER of Poland, MALON of Biddeford.

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1 Be it enacted by the People of the State of Maine as follows:

2 Sec. 1. 5 MRSA §12004-I, sub-§73-C is enacted to read:

3 73-C.

Psilocybin

Maine Psilocybin Advisory Board

Expenses and

Legislative Per

Diem

28-B MRSA

§2132

4 Sec. 2. 17-A MRSA §1111-A, sub-§1, as amended by PL 2021, c. 669, §1, is

5 further amended to read:

9 1. As used in this section the term "drug paraphernalia" means all equipment, products

10 and materials of any kind that are used or intended for use in planting, propagating,

11 cultivating, growing, harvesting, manufacturing, compounding, converting, producing,

12 processing, preparing, packaging, repackaging, storing, containing or concealing a

13 scheduled drug in violation of this chapter or Title 22, section 2383, except that this section

14 does not apply to a person who is authorized to possess cannabis for medical use pursuant

15 to Title 22, chapter 558‑C, to the extent the drug paraphernalia is used for that person's

16 medical use of cannabis; to a person who is authorized to possess cannabis pursuant to Title

17 28‑B, to the extent the drug paraphernalia is used for that person's adult use of cannabis; or

18 to a cannabis store licensed pursuant to Title 28‑B, to the extent that the drug paraphernalia

19 relates to the sale or offering for sale of cannabis by the cannabis store; or to a person who

20 is authorized to possess psilocybin pursuant to Title 28-B, to the extent that the drug

21 paraphernalia is used for that person's personal use of psilocybin, to the extent the licensee

22 is authorized to possess psilocybin or to the extent that the drug paraphernalia relates to the

23 sale or offering for sale of psilocybin. It includes, but is not limited to:

24 A. Kits used or intended for use in planting, propagating, cultivating, growing or

25 harvesting of any species of plant which is a scheduled drug or from which a scheduled

26 drug can be derived;

27 B. Kits used or intended for use in manufacturing, compounding, converting,

28 producing, processing or preparing scheduled drugs;

29 C. Isomerization devices used or intended for use in increasing the potency of any

30 species of plant that is a scheduled drug;

31 E. Scales and balances used or intended for use in weighing or measuring scheduled

32 drugs;

33 F. Dilutants and adulterants, such as quinine hydrochloride, mannitol, mannite,

34 dextrose and lactose, used or intended for use in cutting scheduled drugs;

35 G. Separation gins and sifters, used or intended for use in removing twigs and seeds

36 from, or in otherwise cleaning or refining, marijuana;

37 H. Blenders, bowls, containers, spoons and mixing devices used or intended for use in

38 compounding scheduled drugs;

39 I. Capsules, balloons, envelopes and other containers used or intended for use in

40 packaging small quantities of scheduled drugs; and

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1 J. Containers and other objects used or intended for use in storing or concealing

2 scheduled drugs.

3 Sec. 3. 28-B MRSA, headnote is amended to read:

4 TITLE 28-B

5 ADULT USE CANNABIS AND PSILOCYBIN

6 Sec. 4. 28-B MRSA Pt. 1 is enacted by adding before chapter 1 the following to

7 read:

8 PART 1

9 ADULT USE CANNABIS

10 Sec. 5. 28-B MRSA Pt. 2 is enacted to read:

11 PART 2

12 PSILOCYBIN

13 CHAPTER 5

14 MAINE PSILOCYBIN HEALTH ACCESS ACT

15 SUBCHAPTER 1

16 GENERAL PROVISIONS

17 §2001. Short title

18 This chapter may be known and cited as "the Maine Psilocybin Health Access Act."

19 §2002. Definitions

20 As used in this chapter, unless the context otherwise indicates, the following terms

21 have the following meanings.

22 1. Administration session. "Administration session" means a session in which a client

23 consumes a psilocybin product under the supervision of a psilocybin service facilitator.

24 2. Approved medical provider. "Approved medical provider" means a physician or

25 physician assistant licensed under Title 32, chapter 36 or 48, a certified nurse practitioner

26 licensed under Title 32, chapter 31 or a naturopathic doctor licensed under Title 32, chapter

27 113-B.

28 3. Board. "Board" means the Maine Psilocybin Advisory Board under section 2132.

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1 4. Business entity. "Business entity" means a corporation, limited liability company,

2 limited partnership or other legal entity that is registered with the office of the Secretary of

3 State.

4 5. Client. "Client" means an individual who receives psilocybin services in this State.

5 6. Client information form. "Client information form" means the form required to be

6 completed by a client under subchapter 8.

7 7. Department. "Department" means the Department of Health and Human Services.

8 8. Integration session. "Integration session" means a meeting between a client and a

9 psilocybin service facilitator that may occur after the client completes an administration

10 session.

11 9. Licensee. "Licensee" means a person holding a current, valid license issued under

12 this chapter.

13 10. Licensee representative. "Licensee representative" means an owner, director,

14 officer, manager, employee, agent or other representative of a licensee to the extent that

15 person acts in a representative capacity.

16 11. Manufacture. "Manufacture" means the cultivation, harvesting, production,

17 preparation, propagation, compounding, conversion or processing of a psilocybin product

18 by extraction from substances of natural origin or by means of chemical synthesis, or by a

19 combination of extraction and chemical synthesis, and includes any packaging of the

20 psilocybin product or labeling of its container.

21 12. Personal use amount. "Personal use amount" means the amount of psilocybin

22 authorized for a client's use under section 2091, subsection 1, paragraph A.

23 13. Premises. "Premises" means all public and private enclosed areas as well as areas

24 outside of a building used for activities licensed under this chapter, including

25 manufacturing psilocybin products, operating a psilocybin service center or providing

26 psilocybin services to clients, and includes but is not limited to offices, kitchens, restrooms

27 and storerooms.

28 14. Preparation session. "Preparation session" means a meeting between a

29 prospective client and a psilocybin service facilitator that occurs before an administration

30 session.

31 15. Psilocybin. "Psilocybin" means the naturally occurring compound produced by

32 various species of fungi as well as psilocin, the substance into which psilocybin is

33 converted in the human body.

34 16. Psilocybin Control and Regulation Fund. "Psilocybin Control and Regulation

35 Fund" means the fund established under subchapter 14.

36 17. Psilocybin manufacturing facility. "Psilocybin manufacturing facility" means a

37 facility licensed under subchapter 4.

38 18. Psilocybin product. "Psilocybin product" means psilocybin-producing fungi or

39 mixtures or substances containing a detectable amount of psilocybin. "Psilocybin product"

40 does not include psilocybin services.

41 19. Psilocybin service center. "Psilocybin service center" means a place where the

42 activities licensed under subchapter 5 may be conducted.

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1 20. Psilocybin service center operator. "Psilocybin service center operator" means a

2 person or entity that operates a psilocybin service center.

3 21. Psilocybin service facilitator. "Psilocybin service facilitator" means a person or

4 entity licensed in accordance with subchapter 6 to provide psilocybin services.

5 22. Psilocybin services. "Psilocybin services" means services provided to a client

6 before, during and after the client's consumption of a psilocybin product, including a

7 preparation session, administration session and integration session.

8 23. Risk assessment screening. "Risk assessment screening" means a questionnaire

9 included in a client information form to guide a psilocybin service facilitator in determining

10 whether a client is eligible for psilocybin services as required under section 2081.

11 24. Testing facility. "Testing facility" means a facility licensed under subchapter 7.

12 §2003. Scope

13 1. Limitations. A person may not possess, manufacture or test more than a personal

14 use amount of psilocybin unless that person is a licensee authorized under this chapter.

15 2. Construction. This chapter may not be construed to:

16 A. Require the MaineCare program or private health insurance coverage to reimburse

17 a person for costs of psilocybin products;

18 B. Amend or affect state or federal law pertaining to employment matters;

19 C. Amend or affect state or federal law pertaining to landlord-tenant matters;

20 D. Prohibit a recipient of or applicant for a federal grant from prohibiting the use,

21 possession or manufacture of psilocybin products to the extent necessary to satisfy

22 federal requirements for the grant;

23 E. Prohibit a party to a federal contract or a person applying to be a party to a federal

24 contract from prohibiting the use, possession or manufacture of psilocybin products to

25 the extent necessary to comply with the terms and conditions of the contract or to

26 satisfy federal requirements for the contract;

27 F. Require a person to violate federal law;

28 G. Exempt a person from a federal law or allow the person to obstruct the enforcement

29 of a federal law;

30 H. Permit a person to give away any amount of psilocybin as part of a business

31 promotion or other commercial activity. This provision does not preclude the charitable

32 donation of psilocybin or limit the ability of a psilocybin service center to donate

33 psilocybin or provide psilocybin at reduced cost consistent with department rules; or

34 I. Authorize any activity that is not expressly authorized under this chapter.

35 3. Effect of authorized conduct. Conduct authorized under this chapter may not:

36 A. Constitute child abuse or neglect without a finding of actual threat to the health or

37 welfare of a child based on all relevant factors;

38 B. Be the basis to restrict a person's parenting time with a child without a finding that

39 the parenting time would endanger the child's physical health or significantly impair

40 the child's emotional development;

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1 C. Be the basis for detention, search or arrest or constitute reasonably articulable

2 suspicion of a crime. Psilocybin as permitted by this chapter is not contraband nor

3 subject to seizure and may not be harmed or destroyed;

4 D. Be the basis to deny eligibility for any public assistance program, unless required

5 by federal law; or

6 E. Constitute the use of an illicit substance or otherwise disqualify a person from

7 medical care or medical insurance, including organ transplants.

8 §2004. Rulemaking

9 The department shall adopt all rules necessary to implement, administer and enforce

10 this chapter, including but not limited to rules governing the following:

11 1. Possession limits on premises. The quantity of psilocybin permitted on premises

12 at one time. In adopting rules pursuant to this subsection, the department shall take into

13 consideration the demand for psilocybin services in the State, the number and location of

14 licensees that operate manufacturing facilities and whether the availability of psilocybin

15 products in this State is commensurate with the demand for psilocybin services;

16 2. Age verification. The manner in which a licensee verifies a person's age for the

17 purpose of ensuring that a client is 21 years of age or older;

18 3. Licensing requirements. The application process for licensure under this chapter

19 and annual renewal of licensure;

20 4. License fees. License fees required for applicants applying for licensure in

21 accordance with this chapter. License fees set by the department may not exceed the cost

22 of administering this chapter. Notwithstanding Title 5, section 8071, subsection 3,

23 paragraph B, rules adopted pursuant to this subsection are routine technical rules as defined

24 in Title 5, chapter 375, subchapter 2-A;

25 5. Prevention of diversion to unauthorized persons. The prevention of diversion of

26 psilocybin products to persons that are not permitted to possess or use psilocybin; and

27 6. Administration sessions. A process to allow a psilocybin service facilitator to

28 provide psilocybin services at locations other than a psilocybin service center, including a

29 client's residence or a medical facility.

30 The department may not require a client to be diagnosed with or have any particular

31 medical condition in order to receive psilocybin services.

32 In adopting rules, the department shall consider the recommendations of the board.

33 Except as otherwise provided in this chapter, rules adopted pursuant to this chapter are

34 routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.

35 §2005. Record keeping and inspection of records and premises; notice

36 1. Record keeping; inspection of records. A licensee shall maintain a complete set

37 of all records of the licensee's business transactions, which must be open to inspection and

38 examination by the department upon demand and with 72 hours' notice during all business

39 hours. The department may not require the records of a licensee to be maintained on the

40 premises of the licensee.

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1 2. Inspection of premises. The department may at any time make an examination of

2 premises for which a license has been issued for the purpose of determining compliance

3 with the provisions of this chapter and the rules adopted pursuant to this chapter.

4 §2006. Administration sessions outside licensed premises prohibited; exception

5 A client may participate in an administration session only at a psilocybin service center,

6 unless the department authorizes a psilocybin service facilitator to provide psilocybin

7 services to the client at another location.

8 §2007. Delivery and sale of psilocybin to persons under 21 years of age prohibited

9 1. Licensee prohibition. A licensee or licensee representative may not sell or deliver

10 a psilocybin product to a person under 21 years of age. Before selling or providing a

11 psilocybin product to a client, the licensee must require the person to produce one of the

12 following pieces of identification:

13 A. A passport;

14 B. A driver's license;

15 C. A nondriver identification card issued under Title 29-A, section 1410;

16 D. A United States military identification card;

17 E. An identification card issued by one of the federally recognized Indian tribes in this

18 State; or

19 F. Any other identification card issued by a state or territory of the United States that

20 bears a photograph of the person, the name of the person, the person's date of birth and

21 a physical description of the person.

22 A licensee or licensee representative is not in violation of this subsection if the licensee or

23 licensee representative reasonably relied on an identification provided by a person that did

24 not accurately provide that person's age.

25 A person who violates this subsection commits a civil violation for which a penalty of not

26 more than $500 may be adjudged.

27 2. False identification. A person may not produce a piece of identification under

28 subsection 1 that falsely indicates the person's age.

29 A person who violates this subsection commits a Class E crime.

30 §2008. Psilocybin product to visibly intoxicated person prohibited

31 A person may not sell, give or otherwise make available a psilocybin product to a

32 person who is visibly intoxicated.

33 A person who violates this section commits a civil violation for which a fine of not

34 more than $500 may be adjudged.

35 §2009. Psilocybin product as a prize prohibited

36 A person may not give a psilocybin product as a prize, premium or consideration for a

37 lottery, contest, game of chance, game of skill or competition of any kind.

38 A person who violates this section commits a civil violation for which a fine of not

39 more than $500 may be adjudged.

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1 §2010. Employment of persons under 21 years of age prohibited

2 A licensee may not employ a person under 21 years of age. The department may verify

3 a person's age in accordance with this section. During an inspection in accordance with

4 this chapter, the department may require proof that a person performing work at the

5 premises is 21 years of age or older. If the person does not provide the department with

6 acceptable proof of age upon request, the department may require the person to

7 immediately cease any activity and leave the premises until the department receives

8 acceptable proof of age. The department may request that the licensee provide proof that

9 the person is 21 years of age or older. Failure of the licensee to respond to the request is

10 prima facie evidence that the licensee has allowed the person to perform work at the

11 premises for which a license has been issued, except that it is an affirmative defense that

12 the person is only temporarily at the premises to make a service, maintenance or repair call

13 or for other purposes and is not an employee of the licensee.

14 A person who violates this section commits a civil violation for which a fine of not

15 more than $500 may be adjudged.

16 §2011. Publication of information related to use of psilocybin

17 The department shall publish on a publicly accessible website available medical,

18 psychological and scientific studies, research and other information, including but not

19 limited to information submitted to the department by the board, relating to the safety and

20 efficacy of psilocybin in treating mental health conditions, including but not limited to

21 substance use disorder, depression, post-traumatic stress disorder, anxiety disorders and

22 end-of-life psychological distress.

23 §2012. Investigation by criminal justice agency of unlawful activity

24 A criminal justice agency may investigate unlawful activity under this chapter and may

25 conduct a criminal history record check of a licensee or its employees during an

26 investigation of unlawful activity in relation to a licensee. A law enforcement officer may

27 enforce any provision of this chapter and may assist the department in enforcing this

28 chapter.

29 A law enforcement officer who has notice, knowledge or reasonable suspicion of a

30 violation of this chapter shall immediately notify the district attorney who has jurisdiction

31 over the violation and furnish that district attorney with names and addresses of any

32 witnesses to the violation or other information related to the violation.

33 §2013. Cooperation of other state entities; immunity

34 All state agencies, including but not limited to the Department of Administrative and

35 Financial Services, shall upon request of the department assist and cooperate with the

36 department to the extent necessary for the department to carry out its duties under this

37 chapter. The Department of Agriculture, Conservation and Forestry may possess, test and

38 dispose of psilocybin products on behalf of the department.

39 Notwithstanding any provision of law to the contrary, the State, its agencies and

40 employees are immune from any liability arising out of the performance or nonperformance

41 of any duty or function, or the exercise of any power, under this chapter or any other law

42 of this State relating to psilocybin products.

43 §2014. Immunity; refusal to serve; insurance

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1 1. Reliance immunity. A licensee or licensee representative may reasonably rely

2 upon all statements, declarations and representations made by a client on a client

3 information form unless a reasonable person would have reason to believe a statement,

4 declaration or representation on the form was incorrect or altered. A licensee or licensee

5 representative who in good faith reasonably relies on statements, declarations and

6 representations made by a client on a client information form in accordance with this

7 subsection may not be found in violation of this chapter for selling or serving a psilocybin

8 product to that person based on those statements, declarations and representations. Nothing

9 in this subsection creates any immunity for a licensee or licensee representative who has

10 otherwise violated this chapter or a rule adopted pursuant to this chapter.

11 2. Refusal to serve. Nothing in this chapter requires a licensee or licensee

12 representative to provide psilocybin services to any person. Except as provided in this

13 section, a licensee or licensee representative may refuse to provide psilocybin services to

14 any person or may cease providing such services to a client for any reason or for no reason

15 as long as those reasons are not on the basis of the person's protected class status as defined

16 in the Maine Human Rights Act. A licensee or licensee representative may not cease

17 providing psilocybin services during an administration session after the client has

18 consumed a psilocybin product except as authorized by the department by rule or as

19 necessary in an emergency.

20 3. Insurance. The department may by rule require licensees to maintain general

21 liability insurance in an amount the department determines is reasonably affordable and

22 available for the purpose of protecting licensees against damages resulting from causes of

23 action related to activities undertaken pursuant to this chapter.

24 4. Discrimination. A licensee may not discharge, demote, suspend or in any manner

25 discriminate or retaliate against an employee of the licensee with regard to promotion,

26 compensation or other terms, conditions or privileges of employment on the basis that the

27 employee has in good faith reported information to the department about an action or

28 inaction of the licensee that the employee reasonably believes is a violation of this chapter

29 or any rules adopted pursuant to this chapter.

30 §2015. Enforceability of contracts

31 A contract involving psilocybin products is not unenforceable on the basis that

32 manufacturing, distributing, dispensing, possessing or using psilocybin products is

33 prohibited by federal law.

34 §2016. Department hotline for verification of license

35 The department shall maintain a telephone hotline for the following persons to inquire

36 if an address is the location of a licensee's premises or is the location of premises for which

37 an application for licensure has been submitted under this chapter:

38 1. Designation by municipality. A person designated by a municipality or a county as

39 a contact for purposes of this chapter;

40 2. Designation by state agency. A person designated by a state agency as a contact for

41 purposes of this chapter; and

42 3. Designation by water district. A person designated by a water district as a contact

43 for purposes of this chapter.

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1 §2017. Confidentiality

2 1. Confidential. The following information obtained by the department under this

3 chapter is confidential and may not be disclosed except as provided in subsection 2:

4 A. Personally identifiable information, as defined by the department by rule, other than

5 the name of a direct owner. For purposes of this paragraph, "direct owner" means an

6 individual listed on an application for a license who is an owner of the business

7 operating or to be operated under the license. "Direct owner" does not include a legal

8 entity other than an individual and does not include an individual who is a general

9 partner, limited partner, member, shareholder or other direct or indirect owner of such

10 a legal entity;

11 B. The address of premises for which a license has been issued or for which an

12 applicant has proposed licensure under this chapter;

13 C. Information related to the security plan or the operational plan for premises for

14 which a license has been issued or for which an applicant has proposed licensure under

15 this chapter; and

16 D. Information related to any record that the department determines by rule to contain

17 proprietary information of a licensee.

18 2. Exceptions. Information designated as confidential under subsection 1 may be

19 disclosed to a law enforcement agency for law enforcement purposes.

20 SUBCHAPTER 2

21 GENERAL LICENSING REQUIREMENTS

22 §2021. License process; license types

23 Beginning January 15, 2025, the department, upon receipt of an application from an

24 applicant for a license under this chapter, shall, upon determination that all applicable

25 requirements for that license are met, issue to the applicant the license. The department

26 may not unreasonably delay processing, approving or denying an application or, if an

27 application is approved, unreasonably delay issuing the license.

28 1. License types. The following licenses may be issued under this chapter in

29 accordance with all applicable requirements of this chapter:

30 A. A psilocybin service center license;

31 B. A psilocybin service facilitator license;

32 C. A psilocybin manufacturing facility license; or

33 D. A testing facility license.

34 Except as otherwise provided in this chapter, the department may not impose any limitation

35 on the number of each type of license that it issues to a qualified applicant or on the total

36 number of each type of license that it issues to qualified applicants pursuant to this chapter.

37 §2022. General licensing criteria

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1 An applicant for a license under this chapter shall meet each of the requirements of this

2 section. An applicant shall disclose in or include with its application the name and address

3 of the applicant and each natural person and business entity that would have a direct or

4 indirect financial interest in the license and the nature and extent of that financial interest

5 and, if applicable, the nature and extent of any financial interest the person or entity has in

6 any other license applied for or issued under this chapter.

7 1. Age. The applicant must be at least 21 years of age. If the applicant is a business

8 entity, every officer, director, manager and general partner of the business entity must meet

9 this requirement.

10 2. Incorporated in State. If the applicant is a business entity, the business entity must

11 be incorporated in the State or otherwise formed or organized under the laws of the State.

12 3. No disqualifying drug offense. The applicant may not have been previously

13 convicted of violating a federal law, state law or local ordinance if the conviction is

14 substantially related to the fitness and ability of the applicant to lawfully carry out activities

15 under the license, as determined by the department by rule. If the applicant is a business

16 entity, every officer, director, manager and general partner of the business entity must

17 satisfy this requirement. The department may not determine that an individual's prior

18 criminal history related to drug offenses relates to the fitness and ability of the applicant to

19 lawfully carry out activities under the license.

20 4. Criminal history record check. The applicant must have submitted to a criminal

21 history record check in accordance with section 2024. If the applicant is a business entity,

22 every officer, director, manager and general partner of the business entity must satisfy this

23 requirement.

24 5. Compliance. An applicant who has previously held a license under this chapter

25 must have a good record of compliance with this chapter and any rules adopted in

26 accordance with this chapter and may not have had a license issued under this chapter

27 revoked for any reason.

28 6. Truthfulness. The applicant may not make any false statements to the department.

29 If the applicant is a business entity, every officer, director, manager and general partner of

30 the business entity is subject to this requirement.

31 7. Health and safety. The applicant must demonstrate an ability to meet any public

32 health and safety standards and industry best practices established by the department by

33 rule.

34 8. Form. The applicant must disclose the applicant's name, address, location where

35 the licensed activities will be conducted and any other information requested by the

36 department in the manner required by the department, except that an applicant for a

37 psilocybin service facilitator license need not identify a location where the licensed

38 activities will be conducted.

39 9. Payment of fees. The applicant must pay the fees established by the department by

40 rule. Fees collected pursuant to this subsection must be deposited into the Psilocybin

41 Control and Regulation Fund.

42 §2023. Additional licensing considerations

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1 1. Financial disclosures. An applicant for a license under this chapter must submit, at

2 the request of the department, the name and address of each person that has a financial

3 interest in the business that will be operated under the license and the nature and extent of

4 that financial interest.

5 2. Limitations on psilocybin service centers. A psilocybin service center may not be

6 located:

7 A. In any area that is not within the limits of an incorporated municipality;

8 B. In any area that is zoned exclusively for residential use; or

9 C. Within 1,000 feet of a public or private elementary or secondary school, unless:

10 (1) The department determines that there is a physical or geographic barrier capable

11 of preventing children from reaching the premises of the psilocybin service center;

12 or

13 (2) The school had not previously been attended by children and was not attended

14 by children at the time the license was issued.

15 A psilocybin service center must meet any other requirements for the facility established

16 by the department by rule.

17 §2024. Criminal history record check

18 The department shall request a criminal history record check for each applicant for a

19 license or permit under this chapter and may at any time require a person applying for a

20 license or permit to submit to a criminal history record check in accordance with this

21 section. If the applicant is a business entity, every officer, director, manager and general

22 partner of the business entity and any individual who holds a financial interest in the

23 business entity of at least 10% must submit to a criminal history record check in accordance

24 with this section.

25 1. Record of public criminal history information required. Criminal history record

26 information obtained from the Maine Criminal Justice Information System, established in

27 Title 16, section 631, pursuant to this section must include a record of public criminal

28 history record information as defined in Title 16, section 703, subsection 8.

29 2. Availability of criminal history record information. The subject of a Federal

30 Bureau of Investigation criminal history record check may obtain a copy of the criminal

31 history record check by following the procedures outlined in 28 Code of Federal

32 Regulations, Sections 16.32 and 16.33. The subject of a state criminal history record check

33 may inspect and review the criminal history record information pursuant to Title 16, section

34 709.

35 3. Use of criminal history record information. State and national criminal history

36 record information obtained by the department under this section may be used only for the

37 purpose of screening an applicant for a license or permit under this chapter.

38 4. Confidentiality. All criminal history record information obtained by the

39 department pursuant to this section is confidential, is for the official use of the department

40 only and may not be disseminated outside of the department or disclosed to any other

41 person or entity except as provided in subsection 2.

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1 5. Rules. The department, after consultation with the Department of Public Safety,

2 Bureau of State Police, State Bureau of Identification, shall adopt rules to implement this

3 section.

4 §2025. Application process; issuance of license

5 1. Forms; payment of fees. An applicant for a license under this chapter shall file an

6 application on a form prepared and furnished by the department for the license sought along

7 with the appropriate application fee.

8 2. Application for multiple licenses. An applicant may apply for and be granted

9 multiple licenses of any license type under this chapter, except that a person may not have

10 a financial interest in:

11 A. More than one psilocybin manufacturing facility;

12 B. More than 5 psilocybin service centers; or

13 C. A testing facility and a psilocybin manufacturing facility or psilocybin service

14 center.

15 3. Each license separate; locations. Each license issued by the department to an

16 applicant under this chapter is separate and distinct from any other license issued by the

17 department to that same applicant under this chapter.

18 A. Except in the case of a psilocybin service facilitator's license, a person must obtain

19 a separate license under this chapter for each geographic location where the licensed

20 activities will occur.

21 B. A person may hold a psilocybin manufacturing license and a psilocybin service

22 center license at the same or different locations.

23 4. Licensee must maintain possession of premises. As a condition of licensure, a

24 licensee must at all times maintain possession of the licensed premises under the license,

25 whether pursuant to a lease, rental agreement or other arrangement for possession of the

26 premises or by virtue of ownership of the premises. If a licensee fails to maintain

27 possession of the licensed premises, the licensee shall immediately cease all licensed

28 activities and may either apply to the department for relocation of the licensed premises or

29 may terminate its license in accordance with this chapter.

30 §2026. Denial of license

31 1. Denial for good cause. The department, for good cause, may deny an application

32 for an initial license, a license renewal, a transfer of ownership interests or a relocation of

33 licensed premises. Denial of an application by the department pursuant to this section

34 constitutes a final agency action as defined in Title 5, section 8002, subsection 4.

35 2. Good cause defined. As used in this section, "good cause" means a finding by the

36 department that an applicant or licensee:

37 A. Has violated any provisions of this chapter or any rules adopted in accordance with

38 this chapter; or

39 B. Has been convicted of a crime or an offense under this chapter, except that the

40 department may not consider a conviction for an offense under this chapter if the date

41 of the conviction is 2 or more years before the date of the application.

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1 "Good cause" does not include a violation by an applicant or licensee of a federal law

2 prohibiting manufacture, use or possession of psilocybin products.

3 3. Grounds for suspension or revocation. The department may suspend or revoke a

4 license issued under this chapter for a violation by the licensee, or by an agent or employee

5 of the licensee, of the provisions of this chapter, rules adopted pursuant to this chapter or

6 the terms, conditions or provisions of the licensee's license or if the department finds:

7 A. That the licensee or an agent or employee of the licensee has made a false

8 representation or statement to the department in order to induce or prevent action by

9 the department;

10 B. That the licensee is insolvent or incompetent or physically unable to carry on the

11 licensed activities;

12 C. That the licensee or an agent or employee of the licensee has misrepresented to a

13 person or the public any psilocybin products sold by the licensee;

14 D. That the licensee or an agent or employee of the licensee has been convicted of any

15 crime or found by a court of competent jurisdiction to have violated any provision of

16 this chapter or of a municipal ordinance, if the violation of that ordinance occurred on

17 the premises for which the license was issued;

18 E. That the licensee or an agent or employee of the licensee has diverted psilocybin

19 products to an entity that is not operating legally under the laws of this State;

20 F. That the licensee or an agent or employee of the licensee has purchased or received

21 a psilocybin product from an unlicensed source or has sold, stored or transferred a

22 psilocybin product in a manner that is not permitted by the licensee's license; or

23 G. That a person with a financial interest in the business operating or to be operated

24 under the license committed or failed to take an act if that act or failure to act would

25 constitute grounds for the department to refuse to issue, or to suspend, revoke or refuse

26 to renew, the license if the person were the licensee or applicant for the license.

27 §2027. License term; renewal

28 A license issued by the department pursuant to this chapter is effective for a period of

29 one year from the date of issuance and may be renewed pursuant to this section.

30 1. Application. A licensee seeking to renew an existing license must file an application

31 for renewal with the department, on forms prepared and furnished by the department, not

32 less than 30 days prior to the date of expiration of the license.

33 2. Expired license. A person whose license has expired shall immediately cease all

34 activities authorized under that license and ensure that all psilocybin in the possession of

35 the person pursuant to that license is forfeited to the department for destruction in

36 accordance with this chapter.

37 §2028. License properties; transfer; leftover product

38 A license issued under this chapter is a personal privilege, expires upon the death of

39 the licensee except as otherwise expressly provided in this chapter, does not constitute

40 property, is not alienable, is not subject to attachment or execution and may not be

41 transferred by will, devise or intestate succession. The department may by rule provide for

42 the manner and conditions under which:

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1 1. Psilocybin products. Psilocybin products left by a deceased, insolvent or bankrupt

2 person or licensee may be sold or otherwise disposed of and any security interest in the

3 products foreclosed or settled;

4 2. Business. The business of a deceased, insolvent or bankrupt licensee may be

5 operated for a reasonable period following the death, insolvency or bankruptcy; and

6 3. Security interest. A person with a security interest in relevant property may

7 continue to operate at the premises for which a license has been issued under this chapter

8 for a reasonable period after default on the indebtedness by the licensee.

9 SUBCHAPTER 3

10 PERMIT REQUIREMENTS; PERMIT VIOLATIONS

11 §2031. Permit required

12 1. Permit. A person who performs any of the following activities for or on behalf of a

13 licensee must have a valid permit issued by the department under this subchapter:

14 A. Providing psilocybin services;

15 B. Possessing, manufacturing, securing or selling of psilocybin products; or

16 C. Verifying a client's age.

17 A licensee shall verify that a person has a valid permit before allowing that person to

18 perform any of the activities listed in this subsection. A permit issued under this subsection

19 is personal to the individual permittee and does not grant any authority to any person other

20 than the named permittee.

21 2. Qualifications. The department shall adopt rules establishing the qualifications for

22 obtaining a permit under this section, the term of a permit issued, procedures for applying

23 for and renewing a permit and reasonable application, issuance and renewal fees for a

24 permit.

25 The qualifications for the permit must include training requirements relating to checking

26 client identification, detecting intoxication, handling psilocybin products, manufacturing

27 psilocybin products, the requirements of this chapter or rules adopted in accordance with

28 this chapter or any other matter the department determines necessary to protect the public

29 health and safety. The department may not require an individual to successfully complete

30 any training more than once, except as a precondition for lifting a suspension of a permit

31 or, after a revocation of a permit, for applying for a new permit. The department or other

32 provider of required training may charge a reasonable fee for that training.

33 3. Denial, revocation or suspension of permit. The department, for good cause, may

34 deny an application for an initial permit or a permit renewal or in an adjudicatory

35 proceeding in accordance with Title 5, chapter 375 may suspend or revoke a permit. Denial

36 of an application by the department pursuant to this section constitutes a final agency action

37 as defined in Title 5, section 8002, subsection 4. As used in this subsection, "good cause"

38 means a finding by the department that:

39 A. A person has violated any provisions of this chapter or any rules adopted in

40 accordance with this chapter; or

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1 B. A person has been convicted of a crime or is convicted of an offense under this

2 chapter, except that the department may not consider a conviction for an offense under

3 this chapter if the date of the conviction is 2 or more years before the date of the

4 application or renewal.

5 "Good cause" does not include the fact that psilocybin products are prohibited by federal

6 law.

7 SUBCHAPTER 4

8 LICENSING AND OPERATING REQUIREMENTS FOR PSILOCYBIN

9 MANUFACTURING FACILITIES

10 §2041. Manufacturing facility license types; authorized and prohibited conduct

11 Subject to the requirements and restrictions of this subchapter and the other applicable

12 requirements of this chapter, the department may issue to an applicant a psilocybin

13 manufacturing facility license. The department may by rule establish different types of

14 psilocybin manufacturing facility licenses that allow the licensee to engage in different

15 types of manufacturing activities. The department may by rule require information from

16 an applicant in addition to what is required under this chapter as a prerequisite to issuing

17 psilocybin manufacturing facility licenses.

18 1. Authorized conduct. A psilocybin manufacturing facility licensee may engage in

19 the following activities in accordance with rules adopted by the department:

20 A. Deliver psilocybin products to premises for which a license has been issued under

21 this chapter;

22 B. Receive psilocybin products from another psilocybin manufacturing facility

23 licensee; and

24 C. Manufacture psilocybin products.

25 A psilocybin manufacturing facility licensee is not required to manufacture a psilocybin

26 product by means of chemical synthesis.

27 2. Prohibited conduct. A psilocybin manufacturing facility licensee may not:

28 A. Manufacture psilocybin products outdoors;

29 B. Sell or deliver a psilocybin product to a person under 21 years of age;

30 C. Employ a person under 21 years of age in manufacturing psilocybin products;

31 D. Make false representations or statements to the department in order to induce or

32 prevent action by the department;

33 E. Supply or sell impure or otherwise deleterious psilocybin products;

34 F. Misrepresent to a person or to the public any psilocybin products; or

35 G. Use information obtained to verify a person's age for any purpose other than

36 verifying a person's age.

37 SUBCHAPTER 5

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1 LICENSING AND OPERATING REQUIREMENTS FOR PSILOCYBIN

2 SERVICE CENTERS

3 §2051. Conduct of psilocybin service center licensees

4 Subject to the requirements and restrictions of this subchapter and the other applicable

5 requirements of this chapter, the department may issue to an applicant a psilocybin service

6 center license.

7 1. Authorized conduct. A psilocybin service center licensee may engage in the

8 following activities in accordance with rules adopted by the department:

9 A. Deliver psilocybin products to premises for which a license has been issued;

10 B. Receive psilocybin products from a psilocybin manufacturing facility licensee or

11 another psilocybin service center licensee; and

12 C. Sell psilocybin products to a client on the premises for which the license has been

13 issued.

14 2. Prohibited conduct. A psilocybin service center licensee may not:

15 A. Sell or deliver a psilocybin product to a person under 21 years of age;

16 B. Employ a person under 21 years of age in the psilocybin service center;

17 C. Make false representations or statements to the department in order to induce or

18 prevent action by the department;

19 D. Supply or sell impure or otherwise deleterious psilocybin products;

20 E. Misrepresent to a person or to the public any psilocybin products; or

21 F. Use information obtained to verify a person's age for any purpose other than

22 verifying a person's age.

23 SUBCHAPTER 6

24 LICENSING AND OPERATING REQUIREMENTS FOR PSILOCYBIN

25 SERVICE FACILITATORS

26 §2061. Minimum qualifications

27 1. Qualifications. In addition to the other applicable licensing requirements required

28 by this chapter, an applicant for a psilocybin service facilitator license must:

29 A. Meet any education or training requirements established by the department by rule,

30 except that the department may not require a degree from an institution of higher

31 education;

32 B. Meet any examination requirements established by the department by rule, except

33 that the department may provide for waivers of examination requirements in cases it

34 determines appropriate. The department shall offer any required examination at least

35 twice annually. The department may appoint a person to conduct or supervise

36 examinations of applicants. An applicant may retake any failed section of the

37 examination in accordance with rules adopted by the department; and

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1 C. Meet any other training, education, skill or fitness requirements adopted by the

2 department by rule, such as:

3 (1) Facilitation skills that are affirming, nonjudgmental and nondirective; and

4 (2) Support skills for clients during an administration session, including specialized

5 skills relating to client safety and clients who may have mental health conditions,

6 ability to establish a proper environment in which psilocybin services occur and

7 social and cultural skills.

8 2. Training course approval. The department shall establish a process to approve

9 training courses for psilocybin service facilitators. To obtain approval of a course, the

10 person providing the course must submit an outline of instruction to the department and to

11 the Department of Education that includes the course topics, total hours of instruction,

12 hours of lectures in theory and hours of instruction in application of practical skills.

13 3. Professional conduct. The department shall establish by rule a code of professional

14 conduct, including a code of ethics, for psilocybin service facilitators. The department

15 shall establish standards of practice and professional responsibility for psilocybin service

16 facilitators.

17 4. Authorized conduct; generally. A psilocybin service facilitator licensee may

18 engage in the following activities in accordance with rules adopted by the department:

19 A. Deliver psilocybin products to premises for which a license has been issued under

20 this chapter;

21 B. Receive psilocybin products from a psilocybin manufacturing facility licensee or

22 another psilocybin service facilitator licensee; and

23 C. Facilitate the use of psilocybin products by a client as part of an administration

24 session.

25 SUBCHAPTER 7

26 LICENSING AND OPERATING REQUIREMENTS FOR TESTING FACILITIES

27 §2071. Qualifications

28 In addition to meeting the licensing requirements under this chapter, an applicant for a

29 testing facility license must meet qualifications, including accreditation standards,

30 established by the department by rule.

31 §2072. Testing standards

32 The department may adopt rules requiring a testing facility licensee to test psilocybin

33 products sold or transferred to others by a psilocybin manufacturing facility licensee. The

34 department may not require a psilocybin product to undergo the same test more than once

35 unless the product is processed into a different type of psilocybin product or the condition

36 of the psilocybin product has fundamentally changed. In adopting rules under this section,

37 the department shall consider the cost of a potential testing procedure and how that cost

38 will affect the cost to clients. The department may not adopt rules that are more restrictive

39 than is reasonably necessary to protect the public health and safety.

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1 The department shall adopt rules establishing standards for testing psilocybin products

2 and identify appropriate tests for different types of psilocybin products and manufacturing

3 processes that are necessary to protect the public health and safety, including but not limited

4 to protection from microbiological contaminants, pesticides, other contaminants, solvents

5 and excessive psilocybin concentration.

6 §2073. Conduct of testing facility licensees

7 1. Authorized conduct. A testing facility licensee may engage in the following

8 activities in accordance with rules adopted by the department:

9 A. Deliver psilocybin products to premises for which a license has been issued under

10 this chapter; and

11 B. Receive psilocybin products from a psilocybin manufacturing facility licensee or

12 another psilocybin service center licensee.

13 2. Prohibited conduct. A testing facility licensee may not:

14 A. Sell or deliver a psilocybin product to a person under 21 years of age;

15 B. Employ a person under 21 years of age in the testing facility;

16 C. Make false representations or statements to the department in order to induce or

17 prevent action by the department;

18 D. Allow licensed premises to be noisy or unsanitary or permit any person on the

19 premises to be lewd or disorderly;

20 E. Supply or sell impure or otherwise deleterious psilocybin products;

21 F. Misrepresent to a person or to the public any psilocybin products; or

22 G. Use information obtained to verify a person's age for any purpose other than

23 verifying a person's age.

24 SUBCHAPTER 8

25 OPERATING REQUIREMENTS FOR PROVIDING PSILOCYBIN SERVICES

26 §2081. Psilocybin services

27 1. Requirements. A psilocybin service center and psilocybin service facilitator shall

28 comply with the requirements of this section. The department shall adopt rules regarding

29 the services provided by psilocybin service centers and the provision of psilocybin services

30 to a client by a psilocybin service facilitator. The rules must:

31 A. Require a psilocybin service facilitator to obtain a complete client information form

32 signed by the prospective client and, if department rules require, an approved medical

33 provider if the prospective client meets the criteria identified by the department in a

34 risk assessment screening;

35 B. Require a psilocybin service facilitator to hold a preparation session with a client

36 before the client participates in an administration session;

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1 C. Require that, during the preparation session, the psilocybin service facilitator review

2 the client information form with the client, including any required review by an

3 approved medical provider;

4 D. Require a psilocybin service facilitator to certify, in a form and manner prescribed

5 by the department, that the facilitator obtained a completed client information form and

6 conducted a preparation session;

7 E. Require a psilocybin service facilitator to deliver a copy of the completed client

8 information form signed by the client and, if department rules require, by an approved

9 medical provider to the psilocybin service center licensee at which the administration

10 session will be held; and

11 F. Permit a preparation session to be held at a psilocybin service center, another

12 approved location or via telehealth.

13 2. Client information form. The department shall adopt rules governing client

14 information and qualifications to receive psilocybin products and psilocybin services. The

15 rules must:

16 A. Require a client to complete and sign a client information form prescribed by the

17 department before a client participates in an administration session. The form must:

18 (1) Solicit from the client such information as may be necessary to enable a

19 psilocybin service center licensee and a psilocybin service facilitator to determine

20 whether the client is eligible to receive psilocybin products and participate in an

21 administration session, including information that may identify risk factors and

22 contraindications or that will assist the licensees in meeting any public health and

23 safety standards and industry best practices during the administration session;

24 (2) Contain the risk assessment screening approved by the board that establishes a

25 clear basis for eligibility and provides guidance for when additional consultation

26 with an approved medical provider is required based on safety concerns;

27 (3) Contain health and safety warnings and disclosures to the client; and

28 (4) Contain the signature and approval of an approved medical provider, when

29 required; and

30 B. Require a psilocybin service facilitator to deliver a copy of the completed and signed

31 client information form to the psilocybin service center licensee at which the

32 administration session will be held and to the psilocybin service facilitator supervising

33 the administration session.

34 3. Additional medical review. The department shall adopt rules regarding when and

35 how medical review by an approved medical provider must be provided prior to the

36 provision of psilocybin products to a client by a psilocybin service facilitator based on

37 criteria identified in a risk assessment screening. The rules must:

38 A. Provide clear guidance for psilocybin service facilitators to determine when

39 additional medical review is indicated by results of the risk assessment screening on

40 the client information form and who is approved to provide the review;

41 B. Provide a standardized format for requiring and obtaining written client consent

42 when further medical review is indicated by the risk assessment screening in order to

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43 determine whether the use of psilocybin products would put the prospective client at

44 increased risk so as to be ineligible to receive psilocybin services at that time;

3 C. For prospective clients who meet any criteria that indicate additional medical review

4 as determined by completion of the risk assessment screening, require an approved

5 medical provider to sign the prospective client's client information form confirming

6 that there is nothing in the client's disclosed health history indicating that use of

7 psilocybin is likely to put the prospective client at an increased risk of an adverse health

8 outcome compared to an average, healthy adult;

9 D. Require that a medical provider who has not previously signed off on a client

10 information form for psilocybin services shall, prior to doing so, submit evidence,

11 satisfactory to the department, of completion of training or education related to

12 psilocybin, which may include self-directed study; and

13 E. Permit an approved medical provider who reviews and provides written

14 confirmation for psilocybin services under this section to use telehealth services as long

15 as it is a synchronous encounter.

16 Nothing in this chapter prevents a professional licensing board from sanctioning a medical

17 provider for failing to properly evaluate or treat a person's medical condition or otherwise

18 violating the applicable standard of care for evaluating or treating medical conditions.

19 4. Informed consent required. The department shall adopt rules requiring a

20 prospective client to review and sign a document informing the client prior to an

21 administration session of the likely effects and potential risks of psilocybin use.

22 5. Administration session. The department shall adopt rules governing administration

23 sessions. The rules must:

24 A. Require that a client complete a preparation session and a client information form

25 confirming eligibility prior to an administration session, including additional medical

26 review if required;

27 B. Require an administration session to occur at a psilocybin service center or other

28 location approved by the department;

29 C. Require a psilocybin service facilitator to certify, in a form and manner prescribed

30 by the department, that the client completed an administration session; and

31 D. Prohibit a psilocybin service facilitator from consuming a psilocybin product during

32 an administration session that the psilocybin service facilitator is supervising.

33 6. Integration session. The department shall adopt rules defining and governing

34 integration sessions. The rules must:

35 A. Require, upon completion of an administration session, that a psilocybin service

36 facilitator offer to the client the opportunity to participate in an integration session;

37 B. Allow a client to decline to participate in an integration session;

38 C. Allow any integration session to occur at a psilocybin service center, at another

39 location or via telehealth; and

40 D. Require a psilocybin service facilitator to certify, in a form and manner prescribed

41 by the department, if a client completed an integration session.

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1 7. Confidentiality. A psilocybin service center and psilocybin service facilitator may

2 not disclose any information that may be used to identify a client or any communication

3 made by a client during the course of providing psilocybin services or selling psilocybin

4 products to the client, except when:

5 A. The client or a person authorized to act on behalf of the client gives consent to the

6 disclosure;

7 B. The client initiates legal action or makes a complaint against the psilocybin service

8 center operator, psilocybin service facilitator or employee of either;

9 C. The communication reveals the intent to commit a crime harmful to the client or

10 others;

11 D. The communication reveals that a minor may have been the victim of a crime or

12 physical, sexual or emotional abuse or neglect;

13 E. Responding to an inquiry by the department made during the course of an

14 investigation into the conduct of a psilocybin service center operator, psilocybin

15 service facilitator or employee under this chapter; or

16 F. The information or communication is required or authorized to be released in

17 accordance with Title 36, chapter 727.

18 SUBCHAPTER 9

19 PERSONAL USE OF PSILOCYBIN

20 §2091. Personal use of psilocybin

21 1. Personal use. Subject to the limitations in this chapter, but notwithstanding any

22 provision of law to the contrary, the following acts are not an offense under state law or the

23 laws of any locality within the State or subject to a civil fine, penalty or sanction or the

24 basis for detention, search or arrest, to deny any right or privilege or to seize or forfeit assets

25 under state law or the laws of any locality if the person engaging in the act is 21 years of

26 age or older:

27 A. Possessing, using, processing, transporting, obtaining, ingesting or giving away

28 without remuneration to a person 21 years of age or older not more than 2 grams of a

29 psilocybin product or 4 ounces of fungi containing psilocybin;

30 B. Possessing, growing, cultivating or processing plants or fungi capable of producing

31 psilocybin for personal use, as long as the plants and fungi and any psilocybin produced

32 in excess of a personal use amount are kept at the person's home or other private

33 residence or upon the grounds of that home or private residence and are secure from

34 access by a person under 21 years of age; and

35 C. Assisting another person who is 21 years of age or older, or allowing property to be

36 used, in any of the actions or conduct permitted under this subsection.

37 §2092. Prior conviction

38 A person who has completed a sentence for a conviction of conduct authorized under

39 this chapter, whether by trial or plea of guilty or nolo contendere, who would not have been

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40 guilty of an offense under this chapter had it been in effect at the time of the offense may

41 file a petition before the trial court that entered the judgment of conviction in the person's

42 case to seal the record of the conviction at no cost. If there is no objection from the district

43 attorney, the court shall automatically seal the record. If there is an objection by the district

44 attorney, a hearing must be held and the court shall determine if the record of the conviction

45 does not qualify to be sealed under this chapter. If the record does not qualify to be sealed,

46 the court shall deny the sealing of the record. Nothing in this section may be construed to

47 diminish or abrogate any rights or remedies otherwise available to the petitioner or

48 applicant.

10 SUBCHAPTER 10

11 LOCAL REGULATION

12 §2101. Preemption; limited regulation

13 The provisions of this chapter are intended to operate uniformly in this State and to

14 preempt any inconsistent municipal regulation. In accordance with this section, a

15 municipality may adopt ordinances that impose reasonable regulations governing activities

16 on premises for which a license has been issued under this chapter, except that a

17 municipality may not require a license to conduct any activity licensed under this chapter,

18 impose a tax or fee on the manufacture or sale of psilocybin products or the sale of

19 psilocybin services or prohibit more than one psilocybin service center from being located

20 in the municipality as long as the distance between the centers is greater than 1,000 feet.

21 For purposes of this subsection, "reasonable regulations" means the following, to the extent

22 consistent with the provisions of this chapter:

23 1. Conditions for manufacturing facilities. Conditions on the manner in which a

24 psilocybin manufacturing facility licensee may manufacture psilocybin products;

25 2. Conditions for psilocybin service centers. Conditions on the manner in which a

26 psilocybin service center licensee may provide psilocybin services;

27 3. Hours. Limitations on the hours during which licensed premises may operate;

28 4. Public access. Requirements related to the public's access to licensed premises;

29 and

30 5. Location. Limitations on where licensed premises may be located.

31 Nothing in this section prohibits a municipality from allowing the manufacture of

32 psilocybin as a farm use on land zoned for farm or forest use.

33 SUBCHAPTER 11

34 LABELING AND PACKAGING; ADVERTISING AND MARKETING; HEALTH

35 AND SAFETY

36 §2111. Labeling requirements

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1 The department shall adopt rules necessary to protect the public health and safety that

2 establish standards for the labeling of psilocybin products.

3 1. Labeling standards. The department may establish different labeling standards for

4 different varieties and types of psilocybin products.

5 2. Preapproval; fee. The department may require a licensee to submit a label intended

6 for use on a psilocybin product for preapproval before the licensee may sell or transfer a

7 psilocybin product bearing the label and the department may impose a fee for the

8 preapproval process.

9 3. Cost. The department shall consider the cost of meeting a potential requirement and

10 how that cost will affect the cost to the client.

11 4. Rules not more restrictive than necessary. The department may not adopt rules

12 governing labeling that are more restrictive than reasonably necessary to protect the public

13 health and safety.

14 5. Imprecise labeling. The department shall by rule prohibit a licensee from placing

15 or allowing the placement of a mark or label on the container of a psilocybin product that

16 is kept for sale if the mark or label does not precisely and clearly indicate the nature of the

17 container's contents or if the mark or label in any way might deceive a person about the

18 nature, composition, quantity, age or quality of the container's contents.

19 6. Deceptive labeling; injurious or adulterated ingredients. The department shall

20 by rule prohibit a licensee from selling any psilocybin product that, in the department's

21 judgment, is deceptively labeled or contains injurious or adulterated ingredients.

22 §2112. Packaging requirements; advertising

23 As necessary to protect the public health and safety, the department shall adopt rules

24 establishing standards for the packaging and advertising of psilocybin products.

25 1. Prohibiting advertising. The department may adopt rules prohibiting advertising

26 psilocybin products to the public.

27 2. Regulating advertising. The department may adopt rules regulating and prohibiting

28 advertising psilocybin services in a manner that is appealing to minors, promotes excessive

29 use, promotes illegal activity, violates the code of professional conduct for psilocybin

30 service facilitator licensees established by the department or otherwise presents a

31 significant risk to public health and safety.

32 3. Packaging standards. The department may establish different packaging standards

33 for different varieties and types of psilocybin products.

34 4. Labeling standards. The department may establish different labeling standards for

35 different varieties and types of psilocybin packages and may consider the effect on the

36 environment of requiring certain packaging.

37 5. Preapproval; fee. The department may require a licensee to submit packaging

38 intended for use on a psilocybin product for preapproval before the licensee may sell or

39 transfer a psilocybin product packaged in the packaging and the department may impose a

40 fee for the preapproval process.

41 6. Cost. The department shall consider the cost of meeting a potential requirement and

42 how that cost will affect the cost to the client.

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1 7. Rules not more restrictive than necessary. The department may not adopt rules

2 governing labeling that are more restrictive than is reasonably necessary to protect the

3 public health and safety.

4 §2113. Dosage requirements

5 The department shall adopt rules establishing the maximum concentration of

6 psilocybin that is permitted in a single serving of a psilocybin product and the number of

7 servings that are permitted in a psilocybin product package.

8 §2114. Prohibition on sale to protect health and safety

9 A person may not sell or offer for sale a psilocybin product unless the psilocybin

10 product complies with the minimum standards prescribed by the provisions of this chapter

11 and the rules adopted pursuant to this chapter. The department may prohibit the sale of a

12 psilocybin product for a reasonable period of time for the purpose of determining whether

13 the psilocybin product complies with the minimum standards prescribed by the provisions

14 of this chapter and the rules adopted pursuant to this chapter.

15 SUBCHAPTER 12

16 LICENSE VIOLATIONS; PENALTIES

17 §2121. General penalty

18 Except as otherwise specified in this chapter, a violation of this chapter or any rules

19 adopted pursuant to this chapter is a civil violation for which a fine of not more than $500

20 may be adjudged.

21 §2122. Administrative penalties

22 1. Administrative penalties; generally. In addition to any other applicable penalty

23 under this chapter, the department, on its own initiative or on complaint and after

24 investigation, notice and the opportunity for a public hearing, may issue an order imposing

25 an administrative penalty in accordance with this section on a licensee or suspend or revoke

26 the licensee's license if the department finds that the licensee or an agent or employee of

27 the licensee has violated any provision of this chapter, the rules adopted pursuant to this

28 chapter or the terms, conditions or provisions of the licensee's license, including but not

29 limited to a finding by the department:

30 A. That the licensee or an agent or employee of the licensee has made a false

31 representation or statement to the department in order to induce or prevent action by

32 the department;

33 B. That the licensee is insolvent or incompetent or physically unable to carry on the

34 licensed activities;

35 C. That the licensee or an agent or employee of the licensee has misrepresented to a

36 person or the public any psilocybin products sold by the licensee;

37 D. That the licensee or an agent or employee of the licensee has been convicted of any

38 crime or found by a court of competent jurisdiction to have violated any provision of

39 this chapter or of a municipal ordinance, if the violation of that ordinance occurred on

40 the premises for which the license was issued;

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1 E. That the licensee or an agent or employee of the licensee has diverted psilocybin

2 products to an entity that is not operating legally under the laws of this State;

3 F. That the licensee or an agent or employee of the licensee has purchased or received

4 a psilocybin product from an unlicensed source or has sold, stored or transferred a

5 psilocybin product in a manner that is not permitted by the licensee's license; or

6 G. That a person with a financial interest in the business operating or to be operated

7 under the license committed or failed to commit an act if that act or failure to act would

8 constitute grounds for the department to refuse to issue, or to suspend, revoke or refuse

9 to renew, the license if the person were the licensee or applicant for the license.

10 The department may not impose any penalty under this section on the basis of a finding

11 that the licensee or an agent or employee of the licensee has violated a provision of federal

12 law governing psilocybin products.

13 2. Amounts; deposit. An administrative penalty imposed by the department on a

14 licensee pursuant to this subchapter may not exceed $5,000 per license violation. The

15 department shall adopt rules setting forth amounts of administrative penalties to be imposed

16 on a licensee based upon specific categories of violations by the licensee. All

17 administrative penalties paid to the department pursuant to this subchapter must be

18 deposited into the Psilocybin Control and Regulation Fund.

19 3. License suspension. A licensee whose license has been suspended pursuant to this

20 subchapter may not, for the duration of the period of suspension, engage in any activities

21 authorized by that license.

22 4. License revocation. A licensee whose license has been revoked pursuant to this

23 subchapter shall cease immediately all activities authorized by the license and shall ensure

24 that all psilocybin and psilocybin products in the possession of the licensee are forfeited to

25 the department for destruction in accordance with this subchapter.

26 5. Enforcement actions may be cumulative. In addition to suspending or revoking a

27 licensee's license, the department may impose an administrative penalty on the licensee

28 consistent with this section.

29 6. Additional penalties may be imposed. Any penalties imposed by the department

30 on a licensee pursuant to this subchapter are in addition to any criminal or civil penalties

31 that may be imposed pursuant to other applicable laws or rules.

32 7. Maine Administrative Procedure Act; appeals. The imposition of an

33 administrative penalty on a licensee or the suspension or revocation of the license of a

34 licensee by the department is governed by the Maine Administrative Procedure Act. A

35 final order of the department imposing an administrative penalty on a licensee or

36 suspending or revoking the licensee's license is a final agency action, as defined in Title 5,

37 section 8002, subsection 4, and the licensee may appeal that final order to the Superior

38 Court in accordance with Rule 80C of the Maine Rules of Civil Procedure.

39 §2123. Disposition of unauthorized psilocybin or psilocybin products of licensee

40 1. Order; destruction of psilocybin or psilocybin products. If the department issues

41 a final order imposing an administrative penalty on or a license suspension or revocation

42 against a licensee pursuant to this subchapter, the department may specify in the order, in

43 addition to any other penalties imposed in the order, that all or a portion of the psilocybin

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44 or psilocybin products in the possession of the licensee are subject to destruction. A

45 licensee subject to a final order directing the destruction of psilocybin or psilocybin

46 products in the possession of the licensee shall forfeit the psilocybin or psilocybin products

47 described in the order to the department for destruction.

5 2. Investigation. If the department is notified by a criminal justice agency that there

6 is a pending investigation of a licensee subject to an order imposed under subsection 1, the

7 department may not destroy any psilocybin or psilocybin products of that licensee until the

8 destruction is approved by the criminal justice agency.

9 3. Conviction of licensee. A court, district attorney or municipal authority involved

10 in trying or finding a violation of this chapter shall notify the department upon final

11 adjudication or conviction of the offense.

12 4. Rules. The department shall adopt rules governing the imposition of administrative

13 penalties, suspensions and revocations under this subchapter, which must include, but are

14 not limited to, provisions relating to notice and conduct of hearings consistent with the

15 Maine Administrative Procedure Act and provisions relating to the disposition of

16 unauthorized psilocybin and psilocybin products of a licensee.

17 SUBCHAPTER 13

18 MAINE PSILOCYBIN ADVISORY BOARD

19 §2131. Definition

20 For purposes of this subchapter, "program development period" means the period

21 beginning October 1, 2024 and continuing until all rules required under this chapter have

22 been initially adopted.

23 §2132. Establishment; purposes

24 The Maine Psilocybin Advisory Board, established in Title 5, section 12004-I,

25 subsection 73-C, is established within the department for the purposes of advising and

26 making recommendations to the department, the Legislature and municipalities regarding

27 the administration of this chapter in a manner that promotes the public health and safety.

28 Recommendations by the board require the approval of a majority of the board's members.

29 §2133. Membership

30 The board consists of 16 members in accordance with this section.

31 1. Ex officio members. The following members serve as ex officio members:

32 A. The Director of the Maine Center for Disease Control and Prevention within the

33 department or the director's designee; and

34 B. The Attorney General or the Attorney General's designee.

35 2. Members appointed by Governor. The Governor shall appoint members in

36 accordance with this subsection. The Governor shall appoint any 4 of the following

37 individuals:

38 A. A state employee who has technical expertise in the field of public health;

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1 B. A representative from a district coordinating council for public health established

2 pursuant to Title 22, section 412, subsection 4;

3 C. A representative of one of the federally recognized Indian tribes in the State;

4 D. A member of the Substance Use Disorder Services Commission, established in Title

5 5, section 12004-G, subsection 13-C;

6 E. A member of the Permanent Commission on the Status of Racial, Indigenous and

7 Tribal Populations, established in Title 5, section 12004-J, subsection 19;

8 F. A member of the Palliative Care and Quality of Life Interdisciplinary Advisory

9 Council, established in Title 5, section 12004-I, subsection 47-I; or

10 G. An individual who represents individuals who provide public health services

11 directly to the public.

12 3. Members appointed by President of Senate. The President of the Senate shall

13 appoint 5 members in accordance with this subsection. The President of the Senate shall

14 appoint:

15 A. A psychologist licensed under Title 32, chapter 56 who has professional experience

16 providing behavioral health services;

17 B. A physician licensed under Title 32, chapter 48; and

18 C. Any 3 of the following individuals:

19 (1) A person with professional expertise conducting scientific research regarding

20 the use of psychedelic compounds in clinical therapy;

21 (2) A person who has experience in the field of mycology;

22 (3) A person who has experience in the field of ethnobotany;

23 (4) A person who has experience in the field of psychopharmacology; or

24 (5) A person who has experience in the field of psilocybin harm reduction.

25 4. Members appointed by Speaker of House of Representatives. The Speaker of the

26 House of Representatives shall appoint 5 members in accordance with this subsection. The

27 Speaker of the House of Representatives shall appoint:

28 A. A naturopathic doctor licensed under Title 32, chapter 113-B;

29 B. An individual with expertise in the field of public health who has a background in

30 academia;

31 C. A representative of one of the federally recognized Indian tribes in the State; and

32 D. Any 2 of the following individuals:

33 (1) A person with professional expertise conducting scientific research regarding

34 the use of psychedelic compounds in clinical therapy;

35 (2) A person who has experience in the field of mycology;

36 (3) A person who has experience in the field of ethnobotany;

37 (4) A person who has experience in the field of psychopharmacology; or

38 (5) A person who has experience in the field of psilocybin harm reduction.

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1 5. Terms; vacancies. Board members, other than ex officio members, serve 2-year

2 terms and are eligible for reappointment. Before the expiration of the term of a member,

3 the appointing authority shall appoint a successor whose term begins on the next January

4 1st. Board members serve at the pleasure of the appointing authority and are not subject to

5 legislative confirmation. If there is a vacancy for cause, the appointing authority shall make

6 an appointment to become immediately effective for the unexpired term.

7 6. Chair. The board shall elect one of its members to serve as chair. The chair serves

8 a one-year term in that office and is eligible for reelection.

9 7. Meeting frequency. Until all rules necessary to implement this chapter have been

10 adopted, the board shall meet at least once every 2 calendar months at a time and place

11 determined by the chair or a majority of the members of the board. Thereafter the board

12 shall meet at least 4 times each year at regular intervals at a time and place determined by

13 the chair or a majority of the members of the board. The board may meet at other times

14 and places by the call of the chair or a majority of the members of the board.

15 8. Quorum. A majority of the board's members constitutes a quorum.

16 9. Establishment of subcommittees. The board may establish subcommittees

17 necessary for the operation of the board.

18 10. Expenses; reimbursement. Board members are entitled to compensation for

19 service on the board and for travel and board-related expenses in accordance with Title 5,

20 section 12004-I, subsection 73-C.

21 §2134. Powers and duties

22 1. Powers. The board may:

23 A. Adopt rules necessary for the operation of the board. Rules adopted pursuant to this

24 section are routine technical rules pursuant to Title 5, chapter 375, subchapter 2-A; and

25 B. Make recommendations to the department related to:

26 (1) Administration of this chapter;

27 (2) Available medical, psychological and scientific studies, research and other

28 information on the safety and efficacy of psilocybin in treating behavioral health

29 conditions, including but not limited to substance use disorder, depression, anxiety

30 disorders and end-of-life psychological distress;

31 (3) Working with clients receiving psilocybin services, including:

32 (a) The requirements, specifications and guidelines for providing psilocybin

33 services to a client, including but not limited to holding and verifying the

34 completion of a preparation session, an administration session and an

35 integration session;

36 (b) The information that must be provided to a client before the client

37 participates in an administration session, including health and safety warnings

38 or other disclosures;

39 (c) The information that must be received from a client to determine whether

40 the client should participate in an administration session, including information

41 that may identify risk factors and contraindications and information related to

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42 any public health or safety standards or industry best practices during the

43 administration session;

3 (d) Transportation needs of a client after the completion of an administration

4 session; and

5 (e) Client access to common or outside areas on the premises of a psilocybin

6 service center;

7 (4) Public health and safety standards and industry best practices for each type of

8 licensee; and

9 (5) Required qualifications and practices of psilocybin service facilitators,

10 including:

11 (a) Adherence to a code of professional and ethical conduct;

12 (b) Required education and training, including but not limited to:

13 (i) Client facilitation skills that are affirming, nonjudgmental and

14 nondirective;

15 (ii) Providing support to clients during an administration session with

16 specialized skills for client safety and clients who may have a mental

17 health condition;

18 (iii) On the appropriate environment in which to provide psilocybin

19 services;

20 (iv) Social and cultural considerations;

21 (v) The form of required training and education; or

22 (vi) Examinations or other requirements; and

23 (c) Holding an administration session, including but not limited to:

24 (i) Individual or group administration sessions; or

25 (ii) Circumstances under which an administration session is considered

26 complete.

27 2. Duties. The board shall:

28 A. Develop and maintain a long-term strategic plan for ensuring that psilocybin

29 services will become and remain a safe, accessible and affordable therapeutic option

30 for all persons who are 21 years of age or older and for whom psilocybin services may

31 be appropriate;

32 B. Monitor and study federal laws, regulations and policies regarding psilocybin; and

33 C. Attempt to meet with the United States Attorney for the District of Maine to discuss

34 this chapter and potential federal enforcement policies regarding psilocybin in this

35 State after the program development period.

36 3. Report. The board shall submit annually a report to the department that contains

37 the recommendations to the department described in subsection 1, paragraph B, the board's

38 long-term strategic plan described in subsection 2, paragraph A and information and

39 updates on federal laws, regulations and policies regarding psilocybin described in

40 subsection 2, paragraphs B and C.

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1 SUBCHAPTER 14

2 PSILOCYBIN CONTROL AND REGULATION FUND

3 §2141. Psilocybin Control and Regulation Fund

4 The Psilocybin Control and Regulation Fund, referred to in this section as "the fund,"

5 is established as a dedicated, nonlapsing fund within the department for the purposes

6 specified in this section.

7 1. Sources of fund. The State Controller shall credit to the fund:

8 A. Money received from the license fees and administrative penalties imposed under

9 this chapter;

10 B. All money from any other source, whether public or private, designated for deposit

11 into or credited to the fund; and

12 C. Interest earned or other investment income on balances in the fund.

13 2. Uses of fund. Money credited to the fund may be used by the department for the

14 purposes of implementing, administering and enforcing this chapter.

15 SUBCHAPTER 15

16 FOOD AND COMMODITY REGULATION

17 §2151. Regulation as food additive

18 Notwithstanding any provision of law to the contrary, the Department of Agriculture,

19 Conservation and Forestry may not establish standards for psilocybin products as a food

20 additive or consider psilocybin products to be an adulterant under Title 7, section 717,

21 unless the concentration of a psilocybin product exceeds acceptable levels established by

22 the department by rule under this chapter.

23 Sec. 6. 36 MRSA c. 727 is enacted to read:

24 CHAPTER 727

25 TAXATION OF PSILOCYBIN PRODUCTS

26 §4961. Definitions

27 As used in this chapter, unless the context otherwise indicates, the following terms

28 have the following meanings.

29 1. Client. "Client" has the same meaning as in Title 28-B, section 2002, subsection 5.

30 2. Department. "Department" means the Department of Health and Human Services.

31 3. Psilocybin. "Psilocybin" has the same meaning as in Title 28-B, section 2002,

32 subsection 15.

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1 4. Psilocybin Control and Regulation Fund. "Psilocybin Control and Regulation

2 Fund" has the same meaning as in Title 28-B, section 2002, subsection 16.

3 5. Psilocybin product. "Psilocybin product" has the same meaning as in Title 28-B,

4 section 2002, subsection 18.

5 6. Psilocybin service center. "Psilocybin service center" has the same meaning as in

6 Title 28-B, section 2002, subsection 19.

7 7. Psilocybin service center operator. "Psilocybin service center operator" has the

8 same meaning as in Title 28-B, section 2002, subsection 20.

9 8. Retail sale. "Retail sale" means any transfer, exchange, gift or barter of a psilocybin

10 product by any person to a client.

11 9. Retail sales price. "Retail sales price" means the price paid for a psilocybin product,

12 excluding tax, to a psilocybin service center operator by or on behalf of a client.

13 §4962. Imposition of tax on retail sale of psilocybin products

14 1. Tax imposed. A tax is imposed upon the retail sale of psilocybin products in this

15 State. The tax imposed by this section is a direct tax on the client, for which payment upon

16 retail sale is required. The tax must be collected at the point of sale of a psilocybin product

17 by a psilocybin service center operator at the time at which the retail sale occurs.

18 A. The tax imposed under this section is at the rate of 15% of the retail sales price of

19 psilocybin products.

20 B. If the tax imposed under this section does not equal an amount calculable to a whole

21 cent, the tax is equal to the next higher whole cent.

22 2. Stated separately. Except as otherwise provided by the State Tax Assessor by rule,

23 the amount of the tax must be separately stated on an invoice, receipt or other similar

24 document that the psilocybin service center operator provides to the client at the time at

25 which the retail sale occurs.

26 3. Prohibitions. The following prohibitions apply.

27 A. A person may not knowingly sell, purchase, install, transfer or possess electronic

28 devices or software programs for the purposes of hiding or removing records of retail

29 sales of psilocybin products or falsifying records of retail sales of psilocybin products.

30 B. A psilocybin service center operator may not discount a psilocybin product or offer

31 a psilocybin product for free if the retail sale of the psilocybin product is made in

32 conjunction with the retail sale of any other item or service.

33 4. Review of rate. The department shall regularly review the rate of tax under this

34 section and make recommendations to the Legislature regarding appropriate adjustments

35 to the rate to ensure the department has sufficient funds to administer and enforce Title

36 28-B, chapter 5 but that the amount of funds, together with fees collected under that chapter,

37 do not exceed the costs of administering and enforcing that chapter.

38 §4963. Collection of tax; refund; credit; penalties

39 The tax imposed upon the client under this chapter must be collected at the point of

40 sale and remitted by each psilocybin service center operator that engages in the retail sale

41 of psilocybin products. The tax is imposed upon the psilocybin service center operator that

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42 is required to collect the tax, and the psilocybin service center operator is liable for the tax

43 as the taxpayer. For the purpose of compensating psilocybin service center operators for

44 expenses incurred in collecting the tax imposed under this chapter, each psilocybin service

45 center operator may deduct and retain 2% of the amount of taxes that are collected by the

46 psilocybin service center operator from all retail sales of psilocybin products conducted by

47 the psilocybin service center operator.

7 1. Filing. A psilocybin service center operator shall file a return with the State Tax

8 Assessor on or before the last day of January, April, July and October of each year for the

9 previous calendar quarter. A psilocybin service center operator shall file each return

10 required under this section regardless of whether any tax is owed.

11 A. The psilocybin service center operator shall pay the tax to the State Tax Assessor

12 in the form and manner prescribed by the State Tax Assessor, but not later than with

13 each quarterly return, without regard to an extension granted under this subsection.

14 B. For good cause, the State Tax Assessor may extend the time for filing a return under

15 this section. The extension may be granted at any time if a written request is filed with

16 the State Tax Assessor during or prior to the period for which the extension may be

17 granted. The State Tax Assessor may not grant an extension of more than 30 days.

18 Interest accumulates on late-filed returns at the rate established in section 186.

19 C. If a psilocybin service center operator fails to file a return or pay the tax as required

20 by this section, the State Tax Assessor may impose penalties or take actions as provided

21 in this chapter.

22 D. Refunds of any overpayment of tax are governed by section 2011, except as follows:

23 (1) The State Tax Assessor shall first apply any overpayment of tax by a psilocybin

24 service center operator to any tax imposed under this chapter that is owed by the

25 psilocybin service center operator;

26 (2) If after any offset under subparagraph (1) the overpayment of tax remains

27 greater than $1,000, the remaining refund must be applied as a credit against the

28 next subsequent calendar quarter as an estimated payment; and

29 (3) The State Tax Assessor may not make a refund of, or credit, any overpayment

30 of tax that was credited to the account of a psilocybin service center operator under

31 subparagraph (2) if the return for that tax period is not filed within 3 years after the

32 due date of that return.

33 §4964. Psilocybin revenue estimate

34 Not later than 30 days before the beginning of each calendar quarter, the department

35 shall forecast and prepare an estimate of the revenue that will be received during the

36 remainder of the current biennium and subsequent 3 biennia pursuant to the tax imposed

37 under this chapter. The estimate may be made on the basis of all pertinent information

38 available to the department. Upon making the estimate, the department shall report the

39 estimate to the Office of Fiscal and Program Review and the State Tax Assessor. The State

40 Tax Assessor shall provide the department any information necessary for the department

41 to perform its duties under this section.

42 §4965. Enforcement; liability; notice of liability; notices of determination and

43 assessment

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1 1. Trust. A person who collects any tax under this chapter shall hold the tax in trust

2 for the State and for payment to the State Tax Assessor in accordance with this chapter.

3 2. Enforcement. Except as otherwise provided in this section, the State Tax Assessor

4 may impose penalties or take actions as provided in chapter 7 against a person who fails to

5 pay taxes required under this chapter in accordance with this chapter.

6 3. Joint liability. More than one officer or employee of a corporation may be held

7 jointly and severally liable for payment of taxes under this chapter.

8 A. Notwithstanding any provision of law to the contrary, if more than one officer or

9 employee of a corporation is jointly and severally liable for payment of taxes, the State

10 Tax Assessor may require any or all of the officers or employees who may be held

11 liable to appear before the State Tax Assessor for a joint determination of liability. The

12 State Tax Assessor shall notify each officer or employee of the time and place set for

13 the determination of liability. Each person notified of a joint determination under this

14 subsection shall appear and present such information as is necessary to establish that

15 person's liability or nonliability for payment of taxes to the State Tax Assessor. If a

16 person who was notified fails to appear, the State Tax Assessor shall make its

17 determination on the basis of all the information and evidence presented. The

18 department's determination is binding on all persons notified and required to appear

19 under this subsection and is a final agency action that may be appealed for review

20 pursuant to Title 5, section 11001.

21 B. If an appeal is taken from the decision of the State Tax Assessor by any person

22 determined to be liable for unpaid taxes under this subsection, each person required to

23 appear before the department under this subsection must be impleaded by the plaintiff.

24 The State Tax Assessor may implead any officer or employee who may be held jointly

25 and severally liable for the payment of taxes. Each person impleaded under this

26 subsection must be made a party to the action and shall make available to all parties in

27 the appeal the information that was presented to the State Tax Assessor. The court may

28 determine that one or more persons impleaded under this subsection are liable for

29 unpaid taxes without regard to any earlier determination by the State Tax Assessor that

30 an impleaded person was not liable for unpaid taxes.

31 C. If a person required to appear before the court on appeal fails or refuses to appear

32 or bring required information in part or in whole, or is outside the jurisdiction of the

33 court, the court shall make its determination on the basis of all the evidence introduced.

34 All evidence presented in the court constitutes a public record and must be available to

35 the parties and the court. The determination of the court is binding on all persons made

36 parties to the action under this subsection.

37 D. This subsection does not preclude a determination by the State Tax Assessor or the

38 court on appeal that more than one officer or employee are jointly and severally liable

39 for unpaid taxes.

40 §4966. Duty to keep receipts, invoices and other records

41 A psilocybin service center operator shall keep receipts, invoices and other pertinent

42 records related to retail sales of psilocybin products in accordance with chapter 7 and in the

43 form required by the State Tax Assessor. Each record must be preserved as provided in

44 section 135 or for as long as the psilocybin service center operator retains the psilocybin

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45 products to which the record relates, whichever is later. During the retention period and at

46 any time prior to the destruction of records, the State Tax Assessor may give written notice

47 to the psilocybin service center operator not to destroy records described in the notice

48 without written permission of the State Tax Assessor. Notwithstanding any provision of

49 law to the contrary, the State Tax Assessor shall preserve reports and returns filed with the

50 department for at least 5 years.

7 §4967. Disclosure of information

8 Notwithstanding any provision of law to the contrary, the State Tax Assessor may

9 disclose information received under this chapter to the department as necessary for the

10 department to carry out the provisions of Title 28-B, chapter 5.

11 §4968. Right to appeal determination of tax liability

12 Except as otherwise provided in this chapter or chapter 7, a final determination of tax

13 liability by the State Tax Assessor under this chapter is a final agency action that may be

14 appealed for review pursuant to Title 5, section 11001.

15 §4969. Duty to return excess tax collected

16 When an amount represented by a psilocybin service center operator at retail to a client

17 as constituting the tax imposed under this chapter is computed upon an amount that is not

18 taxable or is in excess of the taxable amount and is actually paid by the client to the

19 psilocybin service center operator, the excess tax paid must be returned by the psilocybin

20 service center operator to the client upon written notification by the State Tax Assessor or

21 the client. The written notification must contain information necessary to determine the

22 validity of the client's claim. If the psilocybin service center operator does not return the

23 excess tax within 60 days after the mailing of the written notification, the client may appeal

24 to the State Tax Assessor for a refund of the amount of the excess tax, in the manner and

25 within the time allowed under rules adopted by the State Tax Assessor. If excess tax is

26 returned to the client by the State Tax Assessor, the assessor may issue a notice of

27 deficiency for the excess tax to the psilocybin service center operator.

28 §4970. Duties and powers of assessor; rules; interagency cooperation

29 The State Tax Assessor shall administer and enforce this chapter and may adopt rules

30 and procedures necessary for the implementation and enforcement of this chapter. Except

31 as otherwise expressly provided in this chapter, the State Tax Assessor may take any

32 actions under chapter 7 necessary to the proper discharge of the State Tax Assessor's duties

33 under this chapter. The department shall enter into an agreement with the State Tax

34 Assessor for the purpose of administering and enforcing the provisions of this chapter and

35 rules or procedures established by the assessor under this section.

36 §4971. Administrative account; payment of expenses; crediting balance to Psilocybin

37 Control and Regulation Fund

38 All money received by the State Tax Assessor under this chapter must be deposited in

39 a nonlapsing administrative account. The State Tax Assessor may pay expenses for the

40 administration and enforcement of this chapter from the account. After the payment of

41 administrative and enforcement expenses and refunds or credits arising from erroneous

42 overpayments, the State Tax Assessor shall transfer on a quarterly basis the balance of the

43 funds to the Psilocybin Control and Regulation Fund.

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1 Sec. 7. Maine Psilocybin Advisory Board; initial board. Notwithstanding the

2 Maine Revised Statutes, Title 28-B, chapter 5, subchapter 13, the following provisions

3 apply to the Maine Psilocybin Advisory Board.

4 1. Staggered terms for members of Maine Psilocybin Advisory Board. At the first

5 meeting of the Maine Psilocybin Advisory Board, board members shall draw lots to

6 determine members' initial term lengths so that the initial terms of 7 members expire after

7 one year and the initial terms of 7 members expire after 2 years.

8 2. Initial appointments to Maine Psilocybin Advisory Board. The appointing

9 authorities shall appoint initial board members to the Maine Psilocybin Advisory Board no

10 later than October 15, 2023.

11 3. Initial meeting of Maine Psilocybin Advisory Board. The Maine Psilocybin

12 Advisory Board shall hold its first meeting no later than November 15, 2023 at a time and

13 place specified by the Governor.

14 4. Initial reports of Maine Psilocybin Advisory Board. The Maine Psilocybin

15 Advisory Board shall submit no later than April 15, 2024 its findings and recommendations

16 to the Department of Health and Human Services regarding available medical,

17 psychological and scientific studies, research and other information related to the safety

18 and efficacy of psilocybin in treating mental health conditions, including but not limited to

19 substance use disorder, depression, anxiety disorders and end-of-life psychological

20 distress. The Maine Psilocybin Advisory Board shall submit no later than October 15, 2024

21 its findings and recommendations to the Department of Health and Human Services

22 regarding the board's long-term strategic plan described in Title 28-B, section 2134,

23 subsection 2, paragraph A, information and updates on federal laws, regulations and

24 policies regarding psilocybin as described in Title 28-B, section 2134, subsection 2,

25 paragraphs B and C and proposed rules for the implementation of this Act.

26 Sec. 8. Rulemaking by Department of Health and Human Services. The

27 Department of Health and Human Services shall adopt rules no later than July 15, 2024 in

28 order to implement, administer and enforce the Maine Revised Statutes, Title 28-B, chapter

29 5.

30 Sec. 9. Publicly available information regarding psilocybin. No later than

31 December 1, 2024, the Department of Health and Human Services shall first publish

32 information about psilocybin in accordance with the Maine Revised Statutes, Title 28-B,

33 section 2011.

34 Sec. 10. Conforming amendments. The Department of Health and Human

35 Services, in consultation with the Department of Agriculture, Conservation and Forestry

36 and the State Tax Assessor, shall examine laws of this State and develop recommendations

37 for any amendments to those laws to conform to this Act and to otherwise make this Act

38 as consistent as possible in substance to the laws governing psilocybin in Oregon. No later

39 than December 1, 2024, the department shall submit its recommendations together with

40 suggested legislation to the joint standing committee of the Legislature having jurisdiction

41 over health and human services matters. The committee may report out a bill related to the

42 recommendations of the department to the 132nd Legislature in 2025.

Page 36 - 131LR0311(01)

1 SUMMARY

2 This bill enacts the Maine Psilocybin Health Access Act, which establishes a regulatory

3 framework in order to provide psilocybin products to individuals in Maine who are 21 years

4 of age or older.